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Study to Assess Antioxidant Efficacy of Spirulina on oxLDL and Lipids Metabolism on Subjects With Metabolic Syndrome (SPIROX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817620
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : September 18, 2017
Sponsor:
Collaborator:
Biofortis Mérieux NutriSciences
Information provided by (Responsible Party):
Algosource

Tracking Information
First Submitted Date  ICMJE June 27, 2016
First Posted Date  ICMJE June 29, 2016
Last Update Posted Date September 18, 2017
Actual Study Start Date  ICMJE August 24, 2016
Actual Primary Completion Date September 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol [ Time Frame: 12 weeks ]
Defined as the difference V3 (12 weeks) - V1 (baseline) in mU/g
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mU/g
  • Changes in fasting blood oxidized LDL level [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mU/L
  • Changes in fasting blood oxidized LDL level [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mU/L
  • Changes in fasting blood concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/L
  • Changes in fasting blood concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/L
  • Changes in fasting blood concentrations of hsCRP [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mg/L
  • Changes in fasting blood concentrations of hsCRP [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mg/L
  • Changes in fasting blood concentration of total free fatty acid [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L
  • Changes in fasting blood concentration of total free fatty acid [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L
  • Changes in fasting blood concentration of alkaline phosphatase [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in µkat/L
  • Changes in fasting blood concentration of alkaline phosphatase [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in µkat/L
  • Changes in fasting blood concentrations of ASAT (Aspartate aminotransferase) and ALAT (alanine aminotransferase) [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in µkat/L
  • Changes in fasting blood concentrations of ASAT (Aspartate aminotransferase) and ALAT (alanine aminotransferase) [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in µkat/L
  • Changes in fasting blood concentration of total antioxidant status [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in mmol/L
  • Changes in fasting blood concentration of total antioxidant status [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in mmol/L
  • Changes in concentration of urinary isoprostane (F2-isoprostane alpha) [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in ng/mL
  • Changes in concentration of urinary isoprostane (F2-isoprostane alpha) [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in ng/mL
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 30, 2016)
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: Baseline ]
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: 6 weeks ]
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: 12 weeks ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid) [ Time Frame: Baseline ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid) [ Time Frame: 6 weeks ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, propionic acid) [ Time Frame: 12 weeks ]
  • Blood level of Glutathione peroxidase [ Time Frame: Baseline ]
  • Blood level of Glutathione peroxidase [ Time Frame: 6 weeks ]
  • Blood level of Glutathione peroxidase [ Time Frame: 12 weeks ]
  • Superoxide dismutase blood level [ Time Frame: Baseline ]
  • Superoxide dismutase blood level [ Time Frame: 6 weeks ]
  • Superoxide dismutase blood level [ Time Frame: 12 weeks ]
  • Catalase blood level [ Time Frame: Baseline ]
  • Catalase blood level [ Time Frame: 6 weeks ]
  • Catalase blood level [ Time Frame: 12 weeks ]
  • Intestinal microbiota (bacterial DNA extraction in stool) [ Time Frame: Baseline ]
  • Intestinal microbiota (bacterial DNA extraction in stool) [ Time Frame: 12 weeks ]
  • PON-1 (paraoxonase-1) in blood (arylesterase activity) [ Time Frame: Baseline ]
  • PON-1 (paraoxonase-1) in blood (arylesterase activity) [ Time Frame: 12 weeks ]
  • Body weight [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in kg
  • Body weight [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in kg
  • Total energy intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in kcal/day
  • Total energy intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in kcal/day
  • Percentage of energy intake from fat [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %
  • Percentage of energy intake from fat [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %
  • Percentage of energy intake from carbohydrates [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %
  • Percentage of energy intake from carbohydrates [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %
  • Percentage of energy intake from protein [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %
  • Percentage of energy intake from protein [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %
  • Dietary fiber intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Dietary fiber intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Saturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Saturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Mono-unsaturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Mono-unsaturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Poly-unsaturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Poly-unsaturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Heart rate (bpm) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]
  • Systolic blood pressure (mmHg) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]
  • Diastolic blood pressure (mmHg) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]
Original Other Pre-specified Outcome Measures
 (submitted: June 28, 2016)
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: Baseline ]
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: 6 weeks ]
  • Bile acids levels in stool (desoxycholic acid, lithocholic acid, cholic acid, chenodesoxycholic acid, bile salt, ursodesoxycholic acid) [ Time Frame: 12 weeks ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, iso-valerianic acid, propionic acid) [ Time Frame: Baseline ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, iso-valerianic acid, propionic acid) [ Time Frame: 6 weeks ]
  • Short chain fatty acids levels in stool (acetic acid, n-butyric acid, iso-butyric acid, n-valerianic acid, iso-valerianic acid, propionic acid) [ Time Frame: 12 weeks ]
  • Blood level of Glutathione peroxidase [ Time Frame: Baseline ]
  • Blood level of Glutathione peroxidase [ Time Frame: 6 weeks ]
  • Blood level of Glutathione peroxidase [ Time Frame: 12 weeks ]
  • Superoxide dismutase blood level [ Time Frame: Baseline ]
  • Superoxide dismutase blood level [ Time Frame: 6 weeks ]
  • Superoxide dismutase blood level [ Time Frame: 12 weeks ]
  • Catalase blood level [ Time Frame: Baseline ]
  • Catalase blood level [ Time Frame: 6 weeks ]
  • Catalase blood level [ Time Frame: 12 weeks ]
  • Intestinal microbiota (bacterial DNA extraction in stool) [ Time Frame: Baseline ]
  • Intestinal microbiota (bacterial DNA extraction in stool) [ Time Frame: 12 weeks ]
  • PON-1 (paraoxonase-1) in blood (arylesterase activity) [ Time Frame: Baseline ]
  • PON-1 (paraoxonase-1) in blood (arylesterase activity) [ Time Frame: 12 weeks ]
  • Body weight [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in kg
  • Body weight [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in kg
  • Total energy intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in kcal/day
  • Total energy intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in kcal/day
  • Percentage of energy intake from fat [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %
  • Percentage of energy intake from fat [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %
  • Percentage of energy intake from carbohydrates [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %
  • Percentage of energy intake from carbohydrates [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %
  • Percentage of energy intake from protein [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in %
  • Percentage of energy intake from protein [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in %
  • Dietary fiber intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Dietary fiber intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Saturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Saturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Mono-unsaturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Mono-unsaturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Poly-unsaturated fatty acid intake [ Time Frame: 6 weeks ]
    Defined as the difference V2 (6 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Poly-unsaturated fatty acid intake [ Time Frame: 12 weeks ]
    Defined as the difference V3 (12 weeks) - V1 (baseline) in g/day (absolute quantities)
  • Heart rate (bpm) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]
  • Systolic blood pressure (mmHg) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]
  • Diastolic blood pressure (mmHg) [ Time Frame: Pre-inclusion (V0), Baseline (V1), 6 weeks (V2) and 12 weeks (V3) ]
 
Descriptive Information
Brief Title  ICMJE Study to Assess Antioxidant Efficacy of Spirulina on oxLDL and Lipids Metabolism on Subjects With Metabolic Syndrome
Official Title  ICMJE Pilot Study to Assess Antioxidant Efficacy of a Spirulina Water Extract on Oxidized LDL Status and Lipids Metabolism on Subjects With Metabolic Syndrome
Brief Summary The purpose of this pilot study is to assess the beneficial effect of a spirulina water extract (product named Spirulysat®) compared to a placebo in the blood level ratio of oxidized LDL / total LDL cholesterol in subjects with metabolic syndrome after 12 weeks of consumption
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Spirulysat®
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Experimental: Spirulysat®
    Food supplement packaged in 10 ml vials called Spirulysat®. This product is a phycocyanin concentrated fresh spirulina water extract (Spirulina Platensis). 2 vials daily to consume in the morning, just before the breakfast, in a glass of water, during 12 weeks (from V1 to V3 visit).
    Intervention: Dietary Supplement: Spirulysat®
  • Placebo Comparator: Placebo
    Placebo with the same characteristics, appearance, packaging and composition as the active formula except for active ingredient (Spirulina) replaced by a classical blue food colorant used to colour desserts. 2 vials daily to consume in the morning, just before the breakfast, in a glass of water, during 12 weeks (from V1 to V3 visit).
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 14, 2017
Actual Primary Completion Date September 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

To be eligible to the study, male and female volunteers will have to fulfil the following criteria (assessment based on the medical examination performed at V0 with a checking at V1):

  • Age between 18 and 65 years (limits included),
  • BMI between 25 and 35 kg/m² (limits included),
  • With metabolic syndrome defined as central obesity : waist circumference > 94 cm for man and > 80 cm for woman associated to at least 2 observed criteria among : Fasting blood triglycerides > 1.5 g/L and/or Fasting blood HDL cholesterol < 0.4 g/L for man and < 0.5 g/L for woman and/or Fasting blood glucose level > 1 g/L and/or Arterial pressure > 130/85 mmHg or under antihypertensive treatment,
  • For women : non menopausal with the same reliable contraception since at least 3 months before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel accepted) or menopausal without or with hormone replacement therapy started at stable dose since at least 3 months before the beginning of the study and agreeing to keep it during the entire duration of the study,
  • Weight stable with +/- 5 % in the last 3 months ,
  • Non smoking or with tobacco consumption < 10 cigarettes / day,
  • Good general and mental health with in the opinion of the investigator : no clinically significant and relevant abnormalities of medical history or physical examination,
  • Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
  • Affiliated with a social security scheme,
  • Agree to be registered on the volunteers in biomedical research file,

After V0 biological analysis the subjects will be eligible to the study on the following criterion :

  • Blood fasting lipid profile not requiring therapeutic intervention meaning professional recommendations (AFSSAPS, 2005).

A re-screening can occur from 2 months after the exit of the study for failure to comply with one or more of the inclusion criteria listed above.

Exclusion Criteria:

Volunteers with the following criteria will be considered as non eligible to the study (assessment based on the medical examination performed at V0 with a checking at V1):

  • Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble...,
  • Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
  • With a history of ischemic cardiovascular event,
  • Having undergone recent surgical procedure (less than 6 months),
  • Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg),
  • With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
  • Pregnant or lactating women or intending to become pregnant within 4 months ahead,
  • Under cholesterol and/or lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped less than 3 months before the V0 visit,
  • Under medication which could affect blood lipid parameters (e.g. long-term corticosteroid systemic drug, systemic antibodies, androgens or enzyme inducers, etc.) or stopped less than 3 months before the V0 visit (antihypertensive stable long-term treatment tolerated),
  • Regular intake of dietary supplements or "functional foods" which are known to have an impact on lipid metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, capsules containing omega-3 fatty acids from fish oils, etc.) or stopped less than 3 months before the V0 visit,
  • Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V0 visit,
  • With significant change in food habits or in physical activity in the 3 months before the V0 visit or not agreeing to keep them unchanged throughout the study,
  • With a current or planned in the next 4 months specific diet (hyper or hypocaloric, vegan, vegetarian...) or stopped less than 3 months before the V0 visit,
  • With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,
  • Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
  • Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 10 hours of significant physical activity a week, walking excluded),
  • Who made a blood donation in the 3 months before the V0 visit or intending to make it within 4 months ahead,
  • Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
  • Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 euros,
  • Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
  • Presenting a psychological or linguistic incapability to sign the informed consent,
  • Impossible to contact in case of emergency,

After V0 biological analysis the subjects will be considered as non eligible to the study on the following criteria :

  • Fasting blood triglycerides > 3.5 g/L (3.95 mmol/L),
  • Blood ASAT, ALAT or GGT (Gamma Glutamyl Transferase) > 3xULN (Upper Limit of Normal),
  • Blood urea > 12.11 mmol/L (value corresponding to 1.5xULN) or creatinine > 125 µmol/L,
  • Blood hsCRP > 10 mg/L,
  • Complete blood count with clinically significant abnormality according to the investigator.

A re-screening can occur from 2 months after the exit of the study for failure to comply with one or more of the exclusion criteria listed above.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02817620
Other Study ID Numbers  ICMJE PEC15039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Algosource
Study Sponsor  ICMJE Algosource
Collaborators  ICMJE Biofortis Mérieux NutriSciences
Investigators  ICMJE
Study Director: Sophie SCHMID Biofortis Mérieux NutriSciences
Principal Investigator: David GENDRE Biofortis Mérieux NutriSciences
PRS Account Algosource
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP